Apical ring for ventricular assist device

ABSTRACT

An apical ring for coupling a conduit of a ventricular assist device to a heart has an annular disk with a central aperture for receiving the conduit. A collar is axially aligned with the central aperture and has a cylindrical shape interrupted by a gap between first and second ends of the collar. The collar has a fixed section joined to the annular disk and has a cantilever section extending from the fixed section to the first end of the collar. A tightener selectively drives the first end toward the second end to close the gap in order to retain the conduit within the collar. The cantilever section includes a relief slot that is expandable for extending a circumferential length of the cantilever section in response to interacting with the conduit when the gap is closed.

CROSS REFERENCE TO RELATED APPLICATIONS

Not Applicable.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH

Not Applicable.

BACKGROUND OF THE INVENTION

The present invention relates in general to cardiac assist systems, and,more specifically, to an apical ring that provides an attachment pointto a patient's heart for clamping an inflow conduit of a pump and forreceiving a plug if the pump is no longer needed.

A heart pump system known as a left ventricular assist system (LVAS) canprovide long term patient support with an implantable pump associatedwith an externally-worn pump control unit and batteries. The LVASimproves circulation throughout the body by assisting the left side ofthe heart in pumping blood. One such system is the DuraHeart® LVASsystem made by Terumo Heart, Inc., of Ann Arbor, Mich. A typical LVASsystem employs a centrifugal pump, an inflow conduit coupling the pumpto the left ventricle, and an outflow conduit coupling the pump to theaorta. The inflow conduit may be integrally formed with a pump housing.The inflow conduit connects to the heart via an attachment cuff. Anexample of an inflow conduit is shown in U.S. Pat. No. 7,048,681,incorporated by reference herein in its entirety.

The apical cuff or ring is the interface and mounting element for thepump and blood inflow tube (i.e., conduit) to the apex of the leftventricle of the heart. The assist device may be mounted to the heartthrough a process of elevating the left ventricle out of the pericardialsac, defibrillating the heart, suturing the ring at the apex, coringthrough the apex inside the ring, inserting the blood inflow conduitthrough the cored hole, and clamping the ring onto the conduit. Thus,the apical ring may perform the functions of 1) providing a sutureattachment point onto the epicardium muscle, 2) sealing againstpotential blood leakage from the left ventricle around or outside of theinflow conduit, 3) permitting axial and/or or rotational adjustment ofthe pump and inflow conduit with respect to the left ventricle duringimplantation, and 4) fixing the inflow conduit in a final position withrespect to the left ventricle.

The apical ring may preferably be provided with a clamping mechanism tofix the inflow conduit into its final position. Because an inflowconduit may typically include a sintered outside surface, there may besignificant variation in the outside diameter of the inflow conduit fromunit to unit in the region which is to be clamped by the apical ring.Consequently, conventional clamps have been made with an adjustablecircumference in view of the variations in the inflow conduit.

Ease of assembly, efficient implantation, and consistency of results areimportant in the context of cardiac surgery. It would be desirable toprovide for a clamping attachment of the inflow conduit with minimal orno adjustment, with low clamping effort, and with a small dimensionalprofile (i.e., footprint) of the clamp mechanism and ring once it isattached to the pump and the heart.

SUMMARY OF THE INVENTION

In one aspect of the invention, an apical ring is provided for couplinga conduit of a ventricular assist device to a heart. An annular disk hasa central aperture for receiving the conduit. A collar is axiallyaligned with the central aperture and has a cylindrical shapeinterrupted by a gap between first and second ends of the collar. Thecollar has a fixed section joined to the annular disk and has acantilever section extending from the fixed section to the first end ofthe collar. A tightener selectively drives the first end toward thesecond end to close the gap in order to retain the conduit within thecollar. The cantilever section includes a relief slot that is expandablefor extending a circumferential length of the cantilever section inresponse to interacting with the conduit when the gap is closed.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front view of a left ventricular assist system having a pumpimplanted into a patient.

FIG. 2 is a perspective view showing the insertion of an inflow conduitthrough an apical ring into the left ventricle.

FIG. 3 is a left-side perspective view of an apical ring of the presentinvention in an open position.

FIG. 4 is a left-side perspective view of the apical ring of FIG. 3 in aclosed position.

FIG. 5 is a front view of the apical ring of FIG. 3 with the clamp leverremoved.

FIG. 6 is a right-side perspective view of the apical ring of FIG. 5.

FIG. 7 is a top view of the apical ring of FIG. 5.

FIGS. 8 and 9 are right-side perspective views of the apical ring ofFIG. 3 is the open and closed positions, respectively.

FIG. 10 is a front view of the apical ring in the open position.

FIG. 11 is a front view showing the operation of the lever and the camsurface in greater detail.

FIG. 12 is an exploded, perspective view showing an attachment of thelever.

FIG. 13 is an exploded, perspective view showing the sealing disk withthe apical ring.

FIG. 14 is a front view showing an alternative embodiment with a pair ofcomplementary levers.

FIG. 15 is a front view showing an alternative embodiment with a screwadjustment.

FIG. 16 is a cross section showing the apical ring being used to clamp aplug for sealing the site when the pump is no longer needed.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Referring to FIG. 1, a patient 10 is shown in fragmentary frontelevational view. Surgically implanted into the patient's abdominalcavity 11 is the pumping portion 12 of a ventricular assist device 13.An inflow conduit 14 conveys blood from the patient's left ventricleinto the pumping portion 12, and an outflow conduit 15 conveys bloodfrom the pumping portion 12 to the patient's ascending thoracic aorta. Apower cable 16 extends from the pumping portion 12 outwardly of thepatient's body via an incision to a compact controller 17. A powersource, such as battery packs 18, is worn on a belt about the patient'swaist and connected with controller 17.

Each of the conduits 14 and 15 may include a tubular metallic housingproximate the pumping portion 12. At the end of inflow conduit 14connected to the patient's heart (preferably at the apex of the leftventricle), and at the end of outflow conduit 15 connected to theascending thoracic aorta, the conduits are generally attached to thenatural tissue by sutures through the use of a sewing ring or cuff sothat blood flow communication is established and maintained. The distalend of the inflow conduit 14 is inserted through the ventricle wall andinto the heart in order to establish blood flow from the heart to thepumping portion 12.

Inflow conduit 14 may be more preferably comprised of a rigid tubeextending axially from the pump housing as shown in FIG. 2. This allowsfor a shorter inflow conduit and for a more compact placement. For bothtypes of conduits, left ventricle 21 is accessed via apical ring or cuff22 sutured to the apex of the heart and surrounding a section of hearttissue that is cored to provide a passage for conduit 14. The outersurface of conduit 14 preferably has a sintered coating in order topromote a stable blood surface and to facilitate sealing/coagulationbetween the outer diameter of conduit 14 and the ventricular wall.Apical ring 22 clamps onto the same sintered surface. Due to variationsin the manufacturing process using sintering, the resulting tolerancerange of the outer diameter creates a challenge for providing consistentclamping without requiring adjustments to be made by a surgeon duringattachment.

A first embodiment of an apical ring for overcoming the foregoingproblems is shown in FIGS. 3-11.

Referring to FIG. 3, an apical ring 24 (preferably formed from amachined titanium alloy or other rigid material such as a biocompatiblethermoplastic resin) may be associated with a sealing disk 25 that issutured to and seals against the outer surface of the left ventricle.Ring 24 includes an annular disk 26 that is disposed against sealingdisk 25. Ring 24 further includes a collar 27 aligned with a centralaperture 23 of disk 26. Collar 27 has a substantially cylindrical shapeinterrupted by a gap 32 between a first end 30 and a second end 31.First and second ends 30 and 31 may preferably be formed as enlargedblocks as shown. Collar 27 has a fixed section 34 anchored to disk 26and a cantilever section 33 extending from fixed section 34 butseparated from disk 26 by a gap 35. By virtue of being suspended,cantilever section 33 provides an adjustable inside diameter in collar27. The initially manufactured placement of cantilever section 33provides an inside diameter sufficiently large to allow easy insertionof the inflow conduit. Cantilever section 33 is subsequently clamped toa lesser inside diameter in order to secure the inflow conduit.

Sealing disk 25 has an inner edge 36 that is coaxial with centralaperture 23 of annular disk 26 and collar 27 and has an inside diameterselected to provide a good seal around the inflow conduit. Sealing disk25 may preferably be comprised of a molded silicone body with a Dacroncovering, for example. A first side of sealing disk 25 bears againstannular disk 26 and a second side bears against the heart. Annular disk26 includes a suturing flange 28 having a plurality of suturing holes 29spaced around suturing flange 28 that may be formed within a trough inorder to protect the sutures. Suturing holes 29 also pass through secondend 31.

A tightener is provided for selectively driving first end 30 towardsecond end 31 to close gap 32 for retaining the conduit within collar 27once it is placed in its final location. The tightener may be comprisedof a C-clamp mechanism as shown in FIGS. 3-11.

The prior art has shown manually adjustable clamps that are operated bymanual adjustment of a screw connection within the clamp. The presentinvention provides automatic adjustment of the clamp to the particularoutside diameter for the particular inflow conduit being received.Cantilever section 33 includes relief slots 40, 41, and 42 penetratingfirst and second edges 43 and 44 of cantilever section 33. Relief slots40-42 are expandable for extending the circumferential length ofcantilever section 33 in response to interaction between the inflowconduit and the clamp when gap 32 is closed (e.g., in the manner ofstretching of its length). More particularly, relief slots 40-42 act asa spring that is extendable around the inflow conduit when the conduithas some extra outer diameter to be accommodated. One or more reliefslots can be used, and preferably at least one relief slot is providedin each circumferential edge 43 and 44. Each individual relief slot isnot coaxial with any other relief slot (i.e., they are all offset asshown in FIG. 3).

The C-clamp of FIGS. 3-11 is comprised of a pivot pin 45 and a lever arm46. Pivot pin 45 is disposed at a substantially fixed location withrespect to annular disk 26 and is adjacent first end 30. As shown in theexploded view of FIG. 12, pivot pin 45 may be attached to second end 31by a screw 47 that passes through first end 30 and is threaded throughpivot pin 45. Thus, pivot pin 45 is maintained at a fixed distance fromsecond end 31. Lever 46 has apertures 48 for receiving the ends of pivotpin 45, whereby lever 46 rotates on pivot pin 45 between an openposition as shown in FIG. 3 and a closed position as shown in FIG. 4.Lever 46 has a cam surface 50 that is slidable against first end 30. Camsurface 50 has a variable profile extending to a gradually larger radiusaway from pivot pin 45 in order to progressively drive first end 31toward second end 30 as lever 46 rotates from the open position to theclosed position.

Referring again to FIG. 3, lever 46 has a push tab 51 at its end toallow a surgeon to easily press on the clamp to move it to the closedposition. Annular disk 26 further includes a thumb tab 52 at a positiondiametrically opposite from first end 30 so that the surgeon can movethe clamp to the closed position by pinching between tabs 51 and 52.FIG. 4 shows lever 46 moved to its closed position with tabs 51 and 52brought face-to-face. In the event that the outer diameter of the inflowconduit is at the upper end of its tolerance range, reaching the closedposition is achievable without requiring a screw adjustment. Closingeffort remains small because relief slots 40-42 can spread slightlyapart to provide the necessary increase of the circumferential length ofcantilever section 33. The overall profile (i.e., size) of ring 24 inits closed position is relatively small and unobtrusive, therebyproviding a compact and efficient system.

As shown in FIGS. 5 and 6, first end 30 may preferably include camfollower surface 55 alongside a groove 56 that receives pivot pin 45. Asseen in FIG. 7, first end 30, cam follower surface 55, and groove 56 aremovable toward second end 31 to close gap 32 by virtue of slit 35between cantilever section 33 and annular disk 26. Protrusions 58 (FIG.6) are received in a central groove 59 (FIG. 9) in lever 46, so thatlever 46 is limited to moving in a plane that is parallel with annulardisk 26.

As best seen in FIG. 10, cam surface 50 on lever 46 provides a minimumthickness section 60 and an increasing thickness section 61. Section 60occupies the space between pivot pin 45 and first end 30 while in theopen position as shown in FIG. 10. A substantially flat section 62 ofcam surface 50 corresponds to the closed position of lever 46. Movingbetween the open and closed positions, cam section 61 progressivelydrives end 30 toward end 31. As shown in FIG. 11, the closed positionshown in solid lines results with lever 46 in the closed position inwhich end 30 is forced toward end 31 so that gap 32 is reduced oreliminated.

FIG. 13 shows a sewing pattern 57 on sealing disk 25 during attachmentby suturing to the heart.

An alternate embodiment shown in FIG. 14 employs a pair of opposedtightening clamps 65 and 67 disposed against collar ends 66 and 68. Ends66 and 68 are preferably each suspended by corresponding cantileversections of the collar. Levers 65 and 67 may be attached to pivot pins70 and 71 that are formed as fixed posts on annular disk 72, forexample. Alternatively, pivot pins 70 and 71 may be interconnected by arod or shaft passing through corresponding holes in ends 66 and 68.

In an alternative embodiment shown in FIG. 15, collar ends 75 and 76 maybe tightened using a threaded screw 77. End 75 is suspended on acantilever section. Relief slots in the collar (not shown) may be usefulwith this screw-type tightener to help ensure that a full tolerancerange of conduit outer diameters can be easily accommodated. Otherhose-clamp type tighteners can also be employed having relief slots.

The present invention facilitates the releasing of the clamp in order toenable the adjustment of the position of the inflow conduit and pump aswell as subsequent removal of the pump and/or inflow conduit forreplacement with a different pump or inflow conduit. In the event ofrecovery of the natural pumping capacity of the heart, a plug 80 shownin FIG. 16 can be clamped into ring 81 so that it passes throughmyocardium 82 and sealing disk 83.

What is claimed is:
 1. A method for providing an interface with the heart using an apical ring, the method comprising: securing an apical ring to a wall of a heart, the apical ring comprising a collar defining a central aperture that provides access into the heart through the wall; inserting a conduit through the central aperture; and manipulating at least two protrusions that extend laterally out from the collar to secure the conduit within the central aperture.
 2. The method according to claim 1, wherein the collar comprises two end portions separated by a gap, and wherein manipulating at least two protrusions comprises pivoting a lever of a clamp by moving a push tab of the lever and a thumb tab on the collar towards each other to progressively move the two end portions closer to each other and reduce the size of the gap.
 3. The method according to claim 2, further comprising releasing the clamp and removing the conduit.
 4. The method according to claim 3, further comprising adjusting an insertion angle of the conduit, inserting the conduit through the central aperture, and manipulating the clamp to progressively reduce the size of the collar to secure the conduit within the central aperture at the adjusted insertion angle.
 5. The method according to claim 2, further comprising replacing the conduit with another conduit and again manipulating the clamp to progressively reduce the size of the collar to secure the conduit within the central aperture of the collar.
 6. The method according to claim 2, wherein the thumb tab is fixed in position relative to the gap.
 7. The method according to claim 2, wherein manipulating the clamp comprises using a single hand to move the push tab relative to the thumb tab.
 8. The method according to claim 2, wherein the clamp comprises a cam surface having a variable profile extending to a gradually larger radius away from the gap, wherein pivoting the lever further comprises engaging the gradually larger radius portion of the cam surface with the second end to increase the force applied to move the second end toward the first end to reduce the size of the gap.
 9. The method according to claim 1, wherein securing the apical ring comprises suturing the apical ring to the wall of the heart.
 10. The method according to claim 1, wherein the wall comprises an apex of a left ventricle of the heart.
 11. The method according to claim 1, further comprising coring a portion of the wall accessible through the central aperture.
 12. A method for providing an interface with the heart using an apical ring, the method comprising: securing an apical ring to an apex of a left ventricle of a heart, the apical ring comprising a sealing disk and a collar defining a central aperture that provides access to a portion of the apex, the collar comprising a first end and a second end separated by an axial gap; inserting an inflow conduit into the central aperture; and pivoting a lever coupled with the second end of the collar from an open position to a closed position to reduce the size of the axial gap.
 13. The method according to claim 12, wherein pivoting the lever further comprises engaging a gradually larger radius of a cam surface with the second end to progressively move the second end toward the first end to reduce the size of the axial gap to secure the inflow conduit within the central aperture.
 14. The method according to claim 12, further comprising pivoting the lever from the closed position to the open position and removing the inflow conduit.
 15. The method according to claim 12, further comprising replacing the inflow conduit with another inflow conduit and again pivoting the lever to reduce the size of the gap.
 16. The method according to claim 12, wherein securing the apical ring comprises suturing the apical ring to the apex.
 17. The method according to claim 12, wherein in the lever comprises a push tab and the collar comprises a thumb tab.
 18. The method according to claim 17, wherein the thumb tab is fixed in position relative to the axial gap.
 19. The method according to claim 18, wherein pivoting the lever comprises using a single hand to move the push tab relative to the thumb tab.
 20. The method according to claim 12, wherein the first end is fixed with the sealing disk and a portion of the collar includes a circumferential gap to provide a cantilever section at a position proximal to the second end, and further comprising pivoting the lever inwardly to flex the cantilever section and thereby reduce the size of the central aperture to secure the inflow conduit.
 21. A method of using an apical ring, the method comprising: providing an apical ring, the apical ring comprising: a sealing disk; a collar defining a central aperture that provides access to a portion of the wall of the heart, the collar comprising an axial gap defined by a first end and a second end; a clamp configured to close the axial gap, the clamp comprising a push tab and a thumb tab; securing the apical ring to a portion of a heart; inserting an inflow conduit through the central aperture; and pivoting a lever of the clamp to progressively move the first end and the second end closer to each other and reduce the size of the axial gap to secure the inflow conduit within the central aperture.
 22. The method according to claim 21, wherein the first end is fixed with the sealing disk and a portion of the collar includes a circumferential gap to provide a cantilever section at a position proximal to the second end, and further comprising pivoting the lever inwardly to flex the cantilever section and thereby reduce the size of the central aperture to secure the inflow conduit.
 23. The method according to claim 22, wherein the apical ring further comprises one or more relief slots extending at least partially through a width of the cantilever section, wherein the one or more relief slots are configured to permit the collar to expand when the axial gap is closed.
 24. The method according to claim 22, wherein the one or more relief slots comprise a first relief slot and a second relief slot, wherein the first relief slot is provided on a first circumferential edge of the cantilever section and the second relief slot is provided on a second circumferential edge of the cantilever section.
 25. The method according to claim 22, further comprising coring the portion of the heart accessible through the central aperture. 